COgnitive Intervention to Restore Attention Using Nature Environment

NCT ID: NCT04485507

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2022-06-08

Brief Summary

Heart failure is a prevalent and serious public health concern with the growing aging population. Patients with heart failure often experience attention impairment that decreases their ability to perform self-care and diminishes their health-related quality of life. In past studies, 15 - 27% of heart failure patients had attention impairment. Attention is fundamental to human activities including self-care management of heart failure. However, cognitive interventions focusing on attention are scarce in heart failure literature. This study focuses on developing a novel cognitive intervention specifically targeting improved attention and testing its efficacy on improving attention, self-care, and health-related quality of life.

The investigators in this study are asking the following 3 questions: 1) does the newly developed cognitive intervention using immersive virtual reality technology (Nature-VR) improve attention compared with the control condition (Urban-VR)?; 2) does Nature-VR intervention improve HF self-care and health-related quality of life compared with Urban-VR control condition?; and 3) are selected biological factors associated with attention function in HF?

The virtual reality-based cognitive intervention (Nature-VR) can be an efficacious intervention for the patients to use and enjoy without burdening already reduced attention. This study has great potential to improve attention and prevent attention impairment, thereby leading to healthier lives among heart failure patients.

Detailed Description

Heart failure (HF) is a prevalent serious chronic illness that affects 6.5 million American. Among HF patients, prevalence of attention impairment is reported as 15-27%. Attention is fundamental to human activities including HF self-care. However, cognitive interventions focusing on attention are scarce in HF. The investigators developed a new cognitive intervention with immersive virtual reality technology and created a prototype of the virtual reality-based natural restorative environment intervention (Nature-VR). The prototype was feasible and showed larger effects in improving attention among 10 HF patients.

In this 2-group randomized controlled pilot study, specific aims are to: 1) examine preliminary efficacy of Nature-VR compared with Urban-VR on improving attention; 2) examine preliminary efficacy of Nature-VR compared with Urban-VR on HF self-care and health-related quality of life; and 3) explore possible biomarkers of attention in HF. This study is important and novel because this is the first intervention study targeting attention using virtual reality technology and investigating possible biomarkers associated with attention in HF patients.

Conditions

Heart Failure; Cognitive Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Nature-VR

Viewing 3D pictures of natural environments

Group Type: EXPERIMENTAL

Nature-VR

Intervention Type: OTHER

Viewing 360 degree nature pictures delivered by a virtual reality headset for 10 minutes/day, 5 days/week for 4 weeks (total of 200 minutes).

Urban-VR

Viewing 3D pictures of urban environments

Group Type: ACTIVE_COMPARATOR

Urban-VR

Intervention Type: OTHER

Viewing 360 degree urban pictures delivered by a virtual reality headset for 10 minutes/day, 5 days/week for 4 weeks (total of 200 minutes).

Interventions

Nature-VR

Viewing 360 degree nature pictures delivered by a virtual reality headset for 10 minutes/day, 5 days/week for 4 weeks (total of 200 minutes).

Intervention Type: OTHER

Urban-VR

Viewing 360 degree urban pictures delivered by a virtual reality headset for 10 minutes/day, 5 days/week for 4 weeks (total of 200 minutes).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• adults (> 21 years)
• diagnosed with chronic HF Stage C
• able to communicate in English

Exclusion Criteria

• uncorrected visual impairment
• major neurological disease (e.g., Alzheimer disease, Parkinson's disease)
• major psychiatric disease (e.g., schizophrenia, bipolar disease)

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Heart Association

OTHER

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Miyeon Jung

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Indiana University School of Nursing

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

1904370750

Identifier Type: -

Identifier Source: org_study_id